Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Mike Robling


Contact details

Director South East Wales Trials Unit
Department of Primary Care and Public Health
7th Floor Neuadd Meirionnydd
Cardiff University
Heath Park
CF14 4YS
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

Version 1.4

Study information

Scientific title

Evaluating the family nurse partnership programme in England: a randomised controlled trial


Building Blocks

Study hypothesis

The purpose of this study is to see if providing young first time mothers with extra support before and after the birth is helpful for both mother and child. We are specifically interested in whether the programme makes a difference to the mother and baby's health and behaviour:
1. During pregnancy and at birth
2. In the first two years after birth

Ethics approval

Research Ethics Committee (REC) for Wales, 17/02/2009, ref: 09/MRE09/08

Study design

Individually randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


First-time pregnancy


This trial will assess the effectiveness of the FNP in England compared with existing universal services, in achieving its stated objectives (namely, to improve pregnancy outcomes, child health and development and parents' economic self-sufficiency).

The trial will start after consent and recruitment into the trial. Participants will be recruited into the trial as soon as the pregnancy is confirmed but before 24 weeks gestation. Participants will be randomised to either entry into the FNP programme arm or to the control arm (universal services), and will be followed up until 2 years after the birth of the child. The whole trial will last 52 months. Interviews (either face-to-face or by telephone) for both arms of the trial will be at baseline, 34 - 36 weeks gestation and 6, 12, 18 and 24 months after birth.

If participants are selected to join the group that receives the FNP programme, they will receive visits from a specially trained 'Family Nurse'. The Family Nurse would normally go to the participants' home, but can see you somewhere else if they prefer. The Family Nurse will visit the participant every week for the first month after they join the study, and then every other week until the baby is born. The Family Nurse will then visit the participant weekly until the baby is six weeks old and then once every two weeks until the child is 20 months old. The last four visits are monthly until the child is 2 years old.

Intervention type



Not Applicable

Drug names

Primary outcome measure

1. Changes in prenatal tobacco use (maternal measure), measured at baseline and 34 - 36 weeks gestation interviews
2. Birth weight (child measure), measured at birth (collected afterwards)
3. Emergency attendances/admissions within two years of birth, measured at all timepoints
4. Proportion of women with a second pregnancy within two years of first birth, measured at all timepoints

Secondary outcome measures

1. Intention to breastfeed
2. Prenatal attachment
3. Injuries and ingestions
4. Breastfeeding (initiation and duration)
5. Language development
6. Education
7. Employment
8. Income/benefits
9. Home (tenure)
10. Health status
11. Self-efficacy
12. Social support
13. Paternal involvement

Timepoints not finalised as of 24/03/2009.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Women aged 19 years or under (at recruitment/consent)
2. Lives within the catchment area covered by the local family nurse partnership (FNP) team
3. First pregnancy confirmed by health services (including those expecting multiple birth) unless previous pregnancy ended in miscarriage, stillbirth or termination
4. Recruited no later than 24 weeks
5. Gillick competent to provide adequate informed consent to research participation including competence in English at conversational level or higher

Participant type


Age group




Target number of participants


Total final enrolment


Participant exclusion criteria

1. Women who at study entry, plan to have their child adopted
2. Women who at study entry, plan to leave the FNP area during the time of the trial either for an extended period of time (3 months or longer) or permanently
3. Women who would require a third person (translator, sign interpreter) to receive the FNP programme

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

South East Wales Trials Unit (SEWTU)
Institute of Primary Care and Public Health Cardiff University 7th Floor Neuadd Meirionnydd Heath Park
CF14 4YS
United Kingdom

Sponsor information


Department of Health (UK)

Sponsor details

Policy Research Programme
Research and Development Directorate
TW11 0XX
United Kingdom

Sponsor type




Funder type


Funder name

Department of Health (UK) (ref: 006/0060) - Policy Research Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2013 protocol in
3. 2015 results in
3. 2016 results in
4. 2018 results in (added 14/05/2019)
5. 2019 analysis in (added 02/01/2020)
6. 2019 economic evaluation in (added 04/06/2020)

Publication citations

Additional files

Editorial Notes

04/06/2020: Publication reference added. 02/01/2020: Publication reference added. 14/05/2019: Publication reference and total final enrolment added. 26/06/2016: publication reference added. 13/01/2015: the following changes were made to the trial record: 1. The overall trial end date was changed from 31/01/2013 to 19/09/2014. 2. The target number of participants was changed from 2400 to 1600.